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Assessment of the Effect of Tegaserod (2 mg Tid and 6 mg Tid) on Dyspeptic Symptoms in Diabetic Patients With Symptoms of Diabetic Gastropathy

This study has been terminated.
(This study was terminated early in April 2005 due to low patient enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00142974
First Posted: September 2, 2005
Last Update Posted: April 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis
  Purpose
This study is being done to evaluate the safety, tolerability and satisfactory relief of tegaserod against dyspeptic symptoms in diabetic patients with symptoms of diabetic gastropathy.

Condition Intervention Phase
Diabetic Gastropathy Drug: Tegaserod Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: Assessment of the Effect of Tegaserod (2 mg Tid and 6 mg Tid) on Dyspeptic Symptoms in Diabetic Patients With Symptoms of Diabetic Gastropathy

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Reduction in weekly mean of a daily composite diabetic gastropathy dyspeptic symptom severity score throughout 6 weeks of treatment.

Secondary Outcome Measures:
  • Weekly global measure of dyspeptic symptom relief.
  • Weekly mean severity of individual dyspeptic symptoms (nausea, vomiting, retching, epigastric/stomach, discomfort/pain, postprandial fullness, bloating, early satiety).

Estimated Enrollment: 120
Study Start Date: May 2004
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • History of Type 1 or insulin-requiring Type 2 diabetes for at least 3 years
  • GI symptoms for at least 2 months before entering study

Exclusion Criteria:

  • Very high body weight
  • Significant diarrhea
  • Ulcers

Symptom severity score collected via diary Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00142974


Locations
Switzerland
Novartis
Basel, Switzerland, 4056
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Basel
  More Information

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00142974     History of Changes
Other Study ID Numbers: CHTF919G2203
First Submitted: August 31, 2005
First Posted: September 2, 2005
Last Update Posted: April 20, 2012
Last Verified: April 2012

Keywords provided by Novartis:
Diabetes, tegaserod, gastropathy

Additional relevant MeSH terms:
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Tegaserod
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs